Respiratory SystemPhase 1NCT01538667
Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases
A Phase 1 study testing Ciprofloxacin (Cipro Inhale, BAYQ3939) in people with Respiratory System, run by Bayer at 1 site in Germany.
Trial summary
The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory System
- What is being tested?
- Ciprofloxacin (Cipro Inhale, BAYQ3939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understanding of the study and written informed consent prior to any study-related procedures
- Additional inclusion criteria for healthy subjects:
- Age: 18 to 65 years (inclusive) at screening visit
- Males
- Non- or ex-smokers who smoked < 5 pack-years and stopped smoking > 1 year prior to screening visit
- Results of laboratory tests within the normal ranges; minor deviations are acceptable provided that they are not judged clinically significant by the investigator
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- Additional inclusion criteria for patients with COPD (chronic obstructive pulmonary disease):
- Age: 40 to 70 years (inclusive) at screening visit
- Males and females
- All patients must have a diagnosis of COPD of Stage II or III according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) Classification (post-bronchodilator forced expiratory volume in 1 second (FEV1): 80% > FEV1 ≥ 30% of predicted values and a post-bronchodilator FEV1/FVC ≤ 70% (FVC = forced vital capacity)
- Minimum smoking history of 10 pack-years
- Additional inclusion criteria for patients with bronchiectasis:
- Age: 18 to 75 years (inclusive) at screening visit
- Males and females
- Diagnosis of bronchiectasis
Who cannot join
- Known hypersensitivity, allergy or intolerance to study drug formulation ingredients
- Febrile illness within 1 week prior to screening visit
- Concomitant severe diseases (judged by the investigator) or diseases which are contraindications for the use of inhaled ciprofloxacin
- Use of ciprofloxacin within 30 days before screening visit
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them, e.g. systemic administration of antibiotics which are subject to renal excretion (e.g. beta-lactam antibiotics, levofloxacin, ofloxacin, etc.), furosemide and antacids
- Donation of more than 450 mL of blood within 4 weeks before screening visit
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- Clinically relevant findings in the ECG
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
- Participation in another clinical study less than 8 weeks prior to screening visit
- Pulmonary exacerbation within the 6 weeks prior to screening
- History of lung transplant or any lung surgery or on any thoracic surgery waiting list
- Additional exclusion criteria for healthy subjects
- Lung function measurements outside normal limits (Normal values: FEV1/FVC > 70% and FEV1 and FVC > 80% of predicted)
- Additional exclusion criteria for patients
- Regular use of daytime oxygen therapy
- Diagnosis of bronchial asthma
- Diagnosis of clinically evident bronchiectasis (COPD patients)
- Total blood eosinophil count >/= 600/mm3.
- Completion of a pulmonary rehabilitation program in the six weeks prior to screening visit or current participation in a pulmonary rehabilitation program
- Change in dose or type of any medications within 4 weeks prior to the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-blinded, Single Dose, Single Centre Trial to Assess the Pulmonary Deposition as Well as Pharmacokinetics, Safety and Tolerability of 99mTc Labeled Ciprofloxacin When Delivered as a Single Dose From a Dry Powder Inhaler to Healthy Subjects With and Without Charcoal Block and Patients Suffering From Bronchiectasis and COPD
The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be evaluated. In this study the radiolabeled substance will be administered and scintigraphy imaging techniques will be used to demonstrate the lung deposition visually. In the healthy subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block). Safety investigations will focus on local tolerability in the lung.
Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug.
Results from this study will be used to show how the drug is distributed in the human lung.
- Conditions
- Respiratory System
- Being tested
- Ciprofloxacin (Cipro Inhale, BAYQ3939)
- Keywords
- Lung, Scintigraphy, Pharmacokinetics, Inhalation, Ciprofloxacin
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (Cipro Inhale, BAYQ3939)Drug
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects
Ciprofloxacin (Cipro Inhale, BAYQ3939)Drug
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block
Ciprofloxacin (Cipro Inhale, BAYQ3939)Drug
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients
Ciprofloxacin (Cipro Inhale, BAYQ3939)Drug
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 2 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 3 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 4 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ciprofloxacin pharmacokinetics including lung deposition
Firstly, scintigraphic imaging, a non-invasive method using a radioactive (99mTc-) label tagged to the formulation, will be used to describe the distribution and deposition of a single inhaled dose of Ciprofloxacin Dry Powder Inhalation (DPI) in the lung quantitatively. Secondly, based on blood sampling over a period of 24 hours after inhalation non-compartmental pharmacokinetic parameters of ciprofloxacin will be calculated to determine the systemic exposure to drug following inhalation of a single 32.5 mg Ciprofloxacin dose.
Measured: Within 24 hours after treatment
Secondary outcomes (1)
Adverse Events collection
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SystemStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538667
- Sponsor's protocol ID
- 11523
- Other IDs
- 2011-000342-38
- Status last verified
- Aug 2014
- First submitted
- 21 Feb 2012
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-blinded, Single Dose, Single Centre Trial to Assess the Pulmonary Deposition as Well as Pharmacokinetics, Safety and Tolerability of 99mTc Labeled Ciprofloxacin When Delivered as a Single Dose From a Dry Powder Inhaler to Healthy Subjects With and Without Charcoal Block and Patients Suffering From Bronchiectasis and COPD
- ClinicalTrials.gov ID
- NCT01538667
- Acronym / sponsor ID
- 11523
- Conditions
- Respiratory System
- Keywords
- Lung, Scintigraphy, Pharmacokinetics, Inhalation, Ciprofloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be evaluated. In this study the radiolabeled substance will be administered and scintigraphy imaging techniques will be used to demonstrate the lung deposition visually. In the healthy subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block). Safety investigations will focus on local tolerability in the lung.
Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug.
Results from this study will be used to show how the drug is distributed in the human lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 2 | Experimental | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 3 | Experimental | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
| Arm 4 | Experimental | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Additional inclusion criteria for healthy subjects:
- Additional inclusion criteria for patients with COPD (chronic obstructive pulmonary disease):
- Additional inclusion criteria for patients with bronchiectasis:
Key exclusion criteria (20 listed)
- Known hypersensitivity, allergy or intolerance to study drug formulation ingredients
- Febrile illness within 1 week prior to screening visit
- Concomitant severe diseases (judged by the investigator) or diseases which are contraindications for the use of inhaled ciprofloxacin
- Use of ciprofloxacin within 30 days before screening visit
- Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them, e.g. systemic administration of antibiotics which are subject to renal excretion (e.g. beta-lactam antibiotics, levofloxacin, ofloxacin, etc.), furosemide and antacids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin (Cipro Inhale, BAYQ3939)50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects | Drug | Arm 1 |
| Ciprofloxacin (Cipro Inhale, BAYQ3939)50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block | Drug | Arm 2 |
| Ciprofloxacin (Cipro Inhale, BAYQ3939)50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients | Drug | Arm 3 |
| Ciprofloxacin (Cipro Inhale, BAYQ3939)50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients | Drug | Arm 4 |
Primary outcome
Ciprofloxacin pharmacokinetics including lung deposition
Time frame: Within 24 hours after treatment
Firstly, scintigraphic imaging, a non-invasive method using a radioactive (99mTc-) label tagged to the formulation, will be used to describe the distribution and deposition of a single inhaled dose of Ciprofloxacin Dry Powder Inhalation (DPI) in the lung quantitatively. Secondly, based on blood sampling over a period of 24 hours after inhalation non-compartmental pharmacokinetic parameters of ciprofloxacin will be calculated to determine the systemic exposure to drug following inhalation of a single 32.5 mg Ciprofloxacin dose.
1 secondary outcome
Adverse Events collection
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciprofloxacin (Cipro Inhale, BAYQ3939) in people with Respiratory System, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ciprofloxacin pharmacokinetics including lung deposition (time frame: Within 24 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.